No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Leslie Ballas · Other
Who this trial is looking for
This trial is looking for patients with muscle invasive bladder cancer that has a specific histology type. Participants will receive chemotherapy with or without immunotherapy before going through further combined treatment with chemotherapy and radiation therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with muscle invasive bladder cancer with variant histology.
My cancer is between stages T2 and T4N0M0.
I have evidence confirmed by tests like TURBT and CT or PET scans.
I can provide written consent and follow study instructions.
You may not be able to join if
I have evidence of widespread cancer in my bladder tissue.
I have hydronephrosis in both kidneys.
I have had radiation therapy in my pelvic area before.
I have received systemic therapy for muscle invasive bladder cancer.
I have another active cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent …
This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +/- IO and is therefore a viable option in patients who are risk of systemic disease spread.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
* Evidence of diffuse cis o…
Inclusion Criteria:
* Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
* Evidence of diffuse cis on pathology
* Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral)
* Prior radiotherapy to the pelvis
* History of systemic therapy for MIBS
* Presence of concurrent cancer (remote history of cancer (\>5 years) allowed if the patient is without evidence of disease)
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
